Key Takeaways Moderna shares climbed 6% after the FDA agreed to review its mRNA-1010 flu vaccine filing.FDA reversed last week's refusal; decision on mRNA-1010 is due by Aug. 5, 2026.mRNA-1010 seeks full nod for 50-64 and accelerated approval for 65, launch eyed for 2026/2027.Shares of Moderna (MRNA) rose 6% on Wednesday after the company announced that the FDA agreed to review its regulatory filing seeking approval for its seasonal influenza vaccine, mRNA-1010. A final decision is expected by Aug. 5, 2026. ...

Core Insights - Moderna reported a loss of $2.11 per share in Q4 2025, which is an improvement compared to the Zacks Consensus Estimate of a loss of $2.60 and a loss of $2.91 in the same quarter last year [1][6] - Total revenues for the quarter were $678 million, exceeding the Zacks Consensus Estimate of $659.5 million, but reflecting a 30% decline year over year due to lower net product sales [1][3] - Year-to-date, Moderna's stock has increased by 26%, outperforming the industry growth of 18% [1] Financial Performance - Overall product sales decreased by 31% year over year to $645 million, primarily due to reduced sales volume of COVID-19 vaccines [3] - The company generated $33 million from grants, collaborations, licensing, and royalty revenues, marking an 18% increase year over year [4] - For the full year 2025, Moderna's total revenues were $1.94 billion, down 40% year over year, with a loss of $7.26 per share, which is an improvement from a loss of $9.28 per share in the previous year [7] Cost Management - Selling, general and administrative (SG&A) expenses were $308 million, down 12% year over year due to reductions in consulting and external services [5] - Research and development (R&D) expenses decreased by 31% to $775 million, reflecting prioritization and efficiency in clinical development [5] Future Guidance - Moderna expects total revenues to grow by up to 10% in 2026 compared to 2025 levels, with a revenue split nearly equal between domestic and international operations [8] - The company is targeting operating expenses of approximately $4.9 billion, including $3 billion for R&D and $1 billion for SG&A [8] - Capital expenditure is projected to be between $0.2 billion and $0.3 billion [8] - Moderna anticipates ending 2026 with cash and cash equivalents between $5.5 billion and $6.0 billion [9] Pipeline Developments - Moderna is developing over 30 mRNA-based investigational candidates across various clinical stages, including a late-stage study for a norovirus vaccine [10] - The company faced a setback when the FDA refused to review its filing for a seasonal flu vaccine due to inadequacies in the supporting study [11] - An important candidate in the pipeline is intismeran autogene, a personalized cancer therapy being evaluated in collaboration with Merck across multiple pivotal studies [12][13]

Core Insights - The fourth-quarter earnings season is ongoing, with major pharmaceutical companies set to announce their results, including AstraZeneca, Incyte, Gilead Sciences, Vertex Pharmaceuticals, and Moderna [1] Industry Overview - Several large pharmaceutical companies such as Johnson & Johnson, Lilly, AbbVie, Biogen, Merck, and Amgen reported better-than-expected fourth-quarter results, surpassing estimates for both earnings and revenues. In contrast, Novartis and Sanofi had mixed results, with earnings exceeding estimates but revenues falling short [2] - As of February 4, 40% of companies in the Medical sector, representing 73.9% of the sector's market capitalization, reported quarterly earnings. Among these, 87.5% exceeded earnings estimates, and 75% surpassed revenue estimates. Year-over-year, earnings increased by 3.3%, while revenues rose by 9.5%. Overall, fourth-quarter earnings for the Medical sector are expected to decline by 1.5%, while sales are projected to increase by 9.1% compared to the previous year [3] Company-Specific Insights AstraZeneca - AstraZeneca's performance has been mixed, with earnings beating estimates in two of the last four quarters, meeting once, and missing once, resulting in an average surprise of 3.81%. The consensus estimate for fourth-quarter sales is $15.78 billion, with earnings expected at $2.18 per share [5] - Key medicines, particularly cancer drugs and diabetes medicine, are expected to drive fourth-quarter sales, supported by strong demand trends [7] - AstraZeneca is scheduled to report its fourth-quarter and full-year 2025 results on February 10 [8] Incyte - Incyte has a mixed history of earnings surprises, beating estimates in three of the last four quarters, with an average surprise of 14.35%. The consensus estimate for fourth-quarter sales is $1.35 billion, with earnings expected at $1.94 per share [9] - Strong sales of Jakafi and expected growth in Opzelura sales are likely to contribute to revenue growth in the fourth quarter [11][12] - Incyte is also set to report its fourth-quarter and full-year 2025 earnings on February 10 [12] Gilead Sciences - Gilead Sciences has a mixed earnings surprise history, beating estimates in three of the last four quarters, with an average surprise of 7.80%. The consensus estimate for fourth-quarter sales is $7.57 billion, with earnings expected at $1.83 per share [13] - Increased sales from Biktarvy and Descovy, along with growth in the Liver Disease portfolio, are anticipated to drive top-line growth [14] - Gilead is scheduled to report its fourth-quarter and full-year 2025 results on February 10 [15] Vertex Pharmaceuticals - Vertex has a mixed earnings surprise history, beating estimates in two of the last four quarters, with an average surprise of 2.01%. The consensus estimate for fourth-quarter sales is $3.17 billion, with earnings expected at $5.07 per share [16] - Revenue growth is likely to be driven by higher sales of its cystic fibrosis medicine, Trikafta, and contributions from newer drugs [18] - Vertex is set to report its fourth-quarter and full-year 2025 results on February 12 [19] Moderna - Moderna has a strong earnings surprise history, beating estimates in all of the last four quarters, with an average surprise of 31.45%. The consensus estimate for fourth-quarter sales is $661.4 million, with expected earnings showing a loss of $2.60 per share [20] - Revenue is expected to be primarily driven by sales of COVID-19 vaccines, although demand has declined recently [22] - Moderna is scheduled to report its fourth-quarter and full-year 2025 earnings on February 13 [23]

Core Insights - Moderna is expected to exceed expectations in its fourth-quarter and full-year 2025 results, with earnings having previously beaten estimates by 76.28% in the last quarter [1] - The Zacks Consensus Estimate for sales is $661.4 million, with an anticipated loss of $2.60 per share [1] Product Portfolio and Sales Expectations - Moderna has three marketed products: two COVID-19 vaccines (Spikevax and mNexspike) and an RSV vaccine (mResvia), with overall product sales estimated at $627 million, primarily driven by COVID-19 vaccines [2] - Minimal sales are expected from the RSV vaccine due to strong competition from GSK and Pfizer [3] Pipeline Developments - A key candidate in Moderna's pipeline is intismeran autogene, a personalized cancer therapy developed in collaboration with Merck, showing promising results in a mid-stage study for high-risk melanoma [4] - Intismeran is currently being evaluated in three pivotal phase III studies, with additional mid-stage studies for other cancer types [5] - Investors are keen on updates regarding the progress of intismeran and other pipeline candidates [5] Combination Vaccine and Regulatory Updates - Moderna's mRNA-1083, a COVID-19/influenza combination vaccine, is on track for FDA resubmission after addressing efficacy data concerns [6] - Positive late-stage data for the standalone flu shot, mRNA-1010, supports the efficacy of the combination vaccine [6] Earnings Performance and Stock Movement - Moderna has consistently beaten earnings estimates over the past four quarters, with an average surprise of 31.45% [7] - Over the past year, Moderna's shares have increased by nearly 29%, compared to the industry's 39% growth [8] Earnings Prediction - The model predicts an earnings beat for Moderna, with an Earnings ESP of +3.16% and a more accurate estimate of a loss of $2.52 per share compared to the consensus estimate of a loss of $2.60 [11][12]

Core Viewpoint - Moderna's mNexspike vaccine has received a positive opinion from the EMA's CHMP, recommending EU approval for its next-generation refrigerator-stable COVID-19 vaccine aimed at individuals aged 12 and older [1][6]. Group 1: Product Approval and Market Strategy - A final decision from the European Commission regarding mNexspike is anticipated soon, with plans for distribution across Europe following regulatory timelines [2]. - mNexspike is Moderna's third product to receive a positive CHMP opinion, joining Spikevax and mResvia, indicating a growing portfolio in the vaccine market [3]. - The approval of mNexspike could enhance Moderna's growth outlook by strengthening its respiratory franchise and generating incremental revenues in the EU starting in 2026-2027 [8]. Group 2: Efficacy and Safety Data - The positive opinion for mNexspike is based on a phase III study with approximately 11,400 participants, demonstrating non-inferior vaccine efficacy compared to Spikevax, with a 9.3% higher relative vaccine efficacy overall and 13.5% higher in adults aged 65 and older [4][6]. - Safety profiles for mNexspike are comparable to Spikevax, showing fewer local reactions and similar rates of systemic adverse events, with common side effects including injection-site pain, fatigue, headache, and myalgia [5][6]. Group 3: Market Context and Demand - COVID-19 remains prevalent in the EU, with ongoing demand for updated vaccines, particularly for high-risk populations such as the elderly, due to waning immunity and the emergence of new variants [9]. - mNexspike offers improved shelf life and storage benefits, which are crucial for distribution in areas with limited cold-chain infrastructure [11].

Core Insights - Moderna reported a loss of $0.51 per share in Q3 2025, which was better than the Zacks Consensus Estimate of a loss of $2.15, compared to an EPS of $0.03 in the same period last year [1][10] - Total revenues for the quarter were $1.02 billion, exceeding the Zacks Consensus Estimate of $860 million, but representing a 45% decline year over year due to lower net product sales [1][10] Revenue Breakdown - Moderna has three marketed vaccines: Spikevax, mNexspike, and mResvia. Product sales fell nearly 47% year over year to $973 million [2] - Sales from COVID-19 vaccines amounted to $971 million, down 46% year over year, attributed to lower vaccination rates and the transition of COVID-19 to a seasonal market [2] - mResvia sales were only $2 million, significantly below the estimated $30 million, and down 80% year over year due to competition from GSK's Arexvy and Pfizer's Abrysvo [3] Operating Costs and Efficiency - SG&A expenses decreased by 5% year over year to $268 million, primarily due to cuts in consulting and external services [5] - R&D expenses were reduced by 30% to $801 million, reflecting a focus on efficiency and prioritization of clinical development [5] Guidance and Outlook - Moderna revised its total revenue guidance for 2025 to a range of $1.6-$2.0 billion, down from $1.5-$2.2 billion [6] - The company also lowered its R&D expense guidance to $3.3-$3.4 billion, from a previous estimate of $3.6-$3.8 billion, while maintaining SG&A and capital expenditure guidance at approximately $1.1 billion and $0.3 billion, respectively [7] Market Reaction - Shares of Moderna rose by 10% in pre-market trading, likely due to the company's cost-cutting measures and improved liquidity outlook, now projected to be between $6.5-$7.0 billion by year-end 2025 [8] Pipeline Developments - Moderna is developing over 40 mRNA-based candidates across various clinical stages, including a personalized cancer therapy in collaboration with Merck [12][16] - The company discontinued development of mRNA-1647 for CMV prevention after failing to meet primary efficacy endpoints but continues to study it in mid-stage trials for bone marrow transplant patients [13] - Positive results from a phase III study for mRNA-1010, a standalone influenza vaccine, have led to plans for regulatory submissions in early 2026 [14] - The company is also working on mRNA-1083, a combination vaccine for COVID-19 and influenza, and is awaiting further guidance from the FDA [15]

Core Insights - Moderna (MRNA) is expected to report Q3 2025 earnings on November 6, with sales estimated at $860 million and a loss of $2.15 per share, indicating a significant decline from the previous year [1] - The consensus estimate for loss per share has widened from $9.50 to $9.74 over the past month [1] Earnings Performance - Moderna has beaten earnings estimates in the last four quarters, with an average surprise of 37.78%, including a 28.76% surprise in the last reported quarter [2][3] Revenue Expectations - The majority of Q3 revenues are anticipated to come from COVID-19 vaccines, with combined sales estimated at $762 million, reflecting a significant decline due to reduced demand for boosters [5][6] - Minimal sales of the RSV vaccine, mResvia, are expected at $30 million, significantly lower than competitors GSK's Arexvy and Pfizer's Abrysvo [7] Pipeline Developments - Moderna is developing over 40 mRNA-based candidates across various clinical stages, with a focus on updates following the recent setback in the CMV vaccine program [8] - The pivotal Phase III study for mRNA-1647 failed to meet primary efficacy endpoints, leading to its discontinuation, although it continues to be studied in mid-stage trials [9] - Investors are also focused on mRNA-1083, a COVID-19/influenza combination vaccine, which is on track for FDA resubmission [10] - Intismeran autogene, a personalized cancer therapy developed with Merck, is undergoing pivotal studies, and updates on its progress are anticipated [11] Stock Performance and Valuation - Year-to-date, Moderna's shares have decreased by 40%, underperforming the industry and the S&P 500 [13][14] - The stock is trading at a premium valuation, with a price/sales ratio of 3.14 compared to the industry average of 2.33 [16] Investment Outlook - Despite significant declines in revenue, Moderna's cash position of approximately $7.5 billion allows for continued investment in pipeline development [18] - The recent CMV vaccine setback has raised concerns about the company's growth trajectory and reliance on other late-stage assets [19][20] - Plans to launch 10 new marketed products by 2028 targeting a market exceeding $30 billion are now clouded by the CMV failure and underwhelming sales of mResvia [21] - Current premium valuation and downward revisions to earnings estimates suggest caution for investors considering building positions in Moderna stock [22]

Core Insights - Moderna's annual sales from its COVID-19 vaccine have significantly declined from over $18 billion, leading to a drop in revenue, earnings, and stock price [1] - The company aims to demonstrate that its success is sustainable, with potential for substantial stock-market returns in the next five years [1] Group 1: Clinical Progress and Pipeline - Moderna's mRNA platform enables faster vaccine development compared to traditional methods, bolstered by increased R&D spending from COVID vaccine profits [3] - Recent clinical and regulatory achievements include the approval of the RSV vaccine, mResvia [4] - The company is focusing on mRNA-4157, a personalized cancer vaccine, which has shown promising results in mid-stage studies for melanoma when combined with Merck's Keytruda [5] - mRNA-4157 is currently in phase 3 trials and is being tested for various cancers, indicating potential for significant future success [6] Group 2: Market Outlook - Despite recent challenges, Moderna's pipeline could lead to improved financial results and stock performance, suggesting that patient investors may see gains in the future [7] - The stock has underperformed due to lackluster financial results, but advancements in the pipeline could enhance its value over the next five years [9]

Core Insights - Moderna is planning to launch up to 10 new marketed products over the next four years, targeting a market opportunity exceeding $30 billion, which is crucial for driving revenue growth and reducing reliance on the COVID-19 vaccine Spikevax [1][8] Product Portfolio and Market Strategy - Spikevax, Moderna's first marketed product, significantly boosted its profitability but has seen a sharp decline in sales as pandemic demand wanes. The company introduced a second product, the RSV vaccine mResvia, but its uptake was weaker than anticipated. Recently, Moderna received approval for a third product, mNexspike, a next-generation version of Spikevax [2][8] - To counteract declining COVID-19 vaccine sales, Moderna is advancing a late-stage pipeline focused on respiratory, infectious diseases, and oncology. Key vaccine programs include mRNA-1647 for CMV, mRNA-1083 for COVID-19 plus influenza, and mRNA-1010 for standalone influenza, with data expected from the CMV study and a regulatory resubmission for the COVID/flu combination vaccine by the end of 2025 [3][8] Cancer Therapy Development - A significant candidate in Moderna's pipeline is intismeran autogene (formerly mRNA-4157), a personalized cancer therapy developed in collaboration with Merck. This therapy is undergoing evaluation in three pivotal phase III studies for melanoma and non-small cell lung cancer, with additional mid-stage studies for high-risk bladder cancers and other indications. A potential launch is targeted for 2027 [4][8] Competitive Landscape - Moderna faces stiff competition from Pfizer and BioNTech, both of which have experienced revenue fluctuations due to declining demand for their jointly developed COVID-19 vaccine, Comirnaty. These companies are also diversifying into adjacent vaccine and therapeutic areas, including a COVID-19 and influenza combination vaccine [5][6] - BioNTech is focusing on oncology as a long-term growth driver, with key candidates like BNT327, an investigational antibody targeting PD-1 and VEGF, being evaluated across various cancer indications [7]

Core Insights - GSK plc is a significant player in the global vaccine market, focusing on vaccines for various infectious diseases [1] Group 1: Vaccine Sales Performance - GSK's vaccine sales in the United States are declining, particularly for the shingles vaccine Shingrix and the RSV vaccine Arexvy, due to a challenging external environment [2] - In the first half of 2025, U.S. sales of Shingrix and Arexvy fell by 56% and 18% respectively, contributing to an overall 11% decline in total vaccine sales at constant exchange rates (CER) [4] - Despite slight improvements in the second quarter of 2025 due to higher sales in Europe, challenges in the U.S. and other international markets are expected to persist [5] Group 2: Regulatory Impact - Revised recommendations from the U.S. Advisory Committee on Immunization Practices (ACIP) in June 2024 have negatively impacted Arexvy's sales, limiting its use for adults aged 50-74 to those at increased risk of severe RSV disease [3][10] Group 3: Pipeline and Future Prospects - GSK has a promising pipeline, including the recently approved pentavalent meningococcal vaccine Penmenvy, which could enhance immunization schedules [6] - The company is also developing vaccines for measles, mumps, rubella, varicella, and various mRNA vaccines, although these will take time to contribute to sales [6] Group 4: Competitive Landscape - Other companies, such as Pfizer and Moderna, have also entered the RSV vaccine market, with their products gaining traction following initial approvals [7] - GSK's RSV vaccine is approved for high-risk individuals aged 50-59, while competitors have broader approvals for younger high-risk populations [8] Group 5: Financial Performance and Valuation - GSK's stock has increased by 19.2% year-to-date, outperforming the industry, which saw a slight decrease of 0.1% [9] - The company's shares are trading at a forward price/earnings ratio of 8.68, which is lower than the industry average of 14.78 and below its 5-year mean of 10.05 [11] - Earnings estimates for 2025 and 2026 have seen slight upward revisions, indicating potential for future growth [13]